Treatment management system

ABSTRACT

A system and a method for managing patient treatment stores in the database a patient history for each patient including data related to observations, test results, diagnoses, treatment regimen(s) and a treatment plan associated with the patient. The treatment plan is administered to the patient and medical device operating data related to the tasks of the associated treatment regimen is stored in the database. A reminder is issued if a task associated with the treatment regimen is not completed on time and the effectiveness of the treatment regimen is evaluated based upon the data stored in the database so that only effective treatment regimens are retained in the system. The system performs treatment planning, treatment monitoring, hospital monitoring, healthcare insurance billing, patient billing, research and analysis support, supply chain management and personnel scheduling.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. provisional patentapplication Ser. No. 60/692,627 filed Jun. 21, 2005.

BACKGROUND OF THE INVENTION

The present invention relates generally to an apparatus and a method formanaging the treatment of hospital patients.

The U.S. Pat. No. 4,839,806 discloses a computerized dispensing ofmedication that provides automated direction and guidance for nurses andallows for data entry regarding whether or not medication was dispensed(See Abstract).

The U.S. Pat. No. 4,857,716 discloses a patient identification andverification system and method that include an overdue drug alert system(Col. 16, lines 28-50) in conjunction with a patient data entry andrecording system. The system also includes checks for drugincompatibility (Col. 14, lines 40-43).

The U.S. Pat. No. 4,916,441 discloses a portable handheld terminal 22having a display screen 40 and a bar code reader 42 that is contemplatedfor use as the point of care data input and retrieval device in apatient care system and in communication with a network file server 24via a local area network. Scheduled actions, defined by a customizedhospital parameter table, may be displayed on the display screen alongwith a warning light and/or an audible beep. (Col. 11, lines 60-67). A“scratch-pad” capability (Col. 12, lines 12-30) is also provided for theterminal, but is recited to be stored in the terminal only.

The U.S. Pat. No. 5,416,695 discloses a method and apparatus foralerting patients and medical personnel of emergency medical situations.An exemplary embodiment of the apparatus is recited for use with anambulatory patient 300 and provides body function data from sensors 320via a telemetry device 310 to a host computer 12. The host computerprovides alerts if any of the body function data exceeds limits set by aphysician or other caregiver.

The U.S. Pat. No. 5,822,544 discloses a patient care and communicationsystem featuring audio, visual, and data communication (See Abstract).

The U.S. Pat. No. 5,912,818 discloses a system for tracking anddispensing medical items that includes a plurality of hook registers 10that are adapted to contain medical devices, medications, or the like.The hook registers are in communication with a computer 84 via a localarea network 82, which is also in communication with an administrator'sworkstation 86, an electronic lock drawer 96, a hospital informationsystem 90, an admission-discharge-transfer system 88, and a medicaldispenser 100. The system discusses the use of alarms (Col. 22, lines28-35).

The U.S. Pat. No. 6,039,251 discloses a method and system for securecontrol of a medical device such as a pump 26 at a patient's home 11from a medical care facility 12.

The U.S. Pat. No. 6,070,761 discloses a vial loading method andapparatus for intelligent admixture and delivery of intravenous drugsthat includes communication with nursing stations, data entry terminals,and patient databases by a hospital network (See FIG. 17).

The U.S. Pat. No. 6,397,190 discloses a veterinary medication monitoringsystem and apparatus that utilizes a PDA and alarm functions for aveterinary treatment system, where the PDA receives data at theveterinarian's office and the PDA provides alarms to the handler/ownerof the animal to provide care. Actions taken are also stored in the PDA.

The U.S. Pat. No. 6,790,198 discloses a patient medication IV deliverypump with wireless communication to a hospital information managementsystem.

The U.S. Patent Application No. 2001/0050610 discloses a hospitalinformatics system that includes a plurality of interconnected modules(chart 200, clinical data entry 400, nursing functions 500, clinicalguide 600, MD functions 700, kardex and pharmacy 800, admitting 900,order entry 1000, and administration 1100—See FIG. 1 and cover page).

The U.S. Patent Application No. 2002/0169636 discloses a system andmethod for managing patient care that includes a plurality of functionalmodules 16, 18, 20, and 22 in communication with a control unit 14 thatcontrols of a patient care device 12 that is in turn in communicationwith a pharmacy system 34. The functional modules are recited to be avariety of pumps, monitors, or input/output devices (see Paragraph 26).Various databases (See FIG. 3) are utilized to provide operationalprotocols or characteristics for the modules 16, 18, 20, and 22.

The U.S. Patent Application No. 2003/0009244, 2004/0073329, and2004/0143459 each disclose a patient care management system 30 andmethod for collecting data and managing patient care that includes aconnection with a pharmacy information system 20 and a hospitalinformation system 40 via a hospital network 5 as well as connectionswith a bedside CPU 80 and at least one infusion pump 92.

The U.S. Patent Application No. 2003/0141981 discloses a system andmethod for operating medical devices, such as an infusion pump 120,wherein a caregiver 116 utilizes a digital assistant 118 to control theinfusion pump. The operation of the infusion pump is also modified byoperating parameters entered by a treating physician (FIG. 5B) andconfirmed by patient IDs such as on a wristband 112a and by a computerat a pharmacy 104. Alarms and errors are generated upon conflicts.

The U.S. Patent Application Nos. 2003/0135388 and 2004/0104271 disclosea medication delivery system for electronically controlling a medicationdelivery device 30 that includes a handheld computing device 22 thatreads data from a patient tag 24 and medical container 28 beforeallowing the device to deliver medication through a catheter 37. Thesystem contemplates preventing the activation of the delivery device ifallergies, etc. are present (See FIG. 39).

The U.S. Patent Application No. 2004/0172299 discloses a system andmethod for facilitating clinical care that allows users to documentnumerous types of clinical interventions including patient assessment12, problem identification 143, recommendations 16, outcome/follow-up18, and status 20 (Paragraph 28 and FIG. 2).

The U.S. Patent Application No. 2004/0193325 discloses a method andapparatus to prevent medication error in a networked infusion systemhaving an infusion device 20 and a computing device 26 connected by anetwork 30 that may be wired or wireless. An alerting device 28 isprovided to notify medical personnel when the medication or the dose isnot clinically acceptable.

SUMMARY OF THE INVENTION

The present invention concerns a patient treatment management systemcomprising: at least one network; at least one hospital informationdatabase in communication said at least one network; at least onetreatment database in communication with said at least one network; andat least one handheld device in communication with said at least onenetwork, said handheld device operable to transmit patient informationto said hospital information database and said treatment database andreceive patient care instructions from said treatment database.

The patient treatment management system according to the presentinvention comprises: at least one network; a treatment management systemdatabase in communication said at least one network; and at least onemodule in communication with said management system database throughsaid at least one network, said at least one module being one of atreatment planning module; a treatment monitoring module; a hospitalperformance monitoring module; a healthcare insurance billing module; apatient billing module; a research and analysis module; a supply chainmanagement module; and a personnel scheduling module.

A patient treatment management system for a hospital according to thepresent invention comprises: at least one database for storing datarelated to a patient including observations, test results, diagnosis andtreatment regimen; at least one healthcare provider terminal for use byhealthcare providers to exchange said data with said database; at leastone monitoring device for sending medical device operating data relatedto the patient during the treatment regimen to said database; and acomputer connected to said at least one database, said at least onehealthcare provider terminal and said at least one monitoring device andgenerating an evaluation of the treatment regimen based upon said data.The system also can include at least one visual control connected tosaid computer for communicating to the healthcare providers informationrelated to a potential problem associated with the treatment regimen.The system further can include at least one administration terminalconnected to said computer for use by administrators to select andmonitor performance measures of the treatment regimen. The systemincludes a software program operated by said computer and having atleast one of a treatment planning module, a treatment monitoring module,a hospital monitoring module, a healthcare insurance billing module, apatient billing module, a research and analysis support module, a supplychain management module and a personnel scheduling module.

A method for managing patient treatment according to the presentinvention comprises the steps of: providing a database; storing in thedatabase standard treatment regimens indexed by diagnosis and applicableto a wide variety of patients; storing in the database data related topatients including observations, test results, diagnoses and treatmentregimens; storing in the database a patient specific treatment planbased on set treatment regimens (possibly customized); storing in thedatabase medical device operating data related to the treatmentregimens; storing in the database the results of executing the treatmentplan to date including any adverse outcomes; and evaluatingeffectiveness of the treatment regimens based upon the data stored inthe database. The method includes determining a diagnosis for a patientbased upon the stored observations and test results data, identifyingall of the stored treatment regimens associated with the diagnosis,either customizing one of the identified treatment regimens or creatinga new treatment regimen, and storing in the database the customizedtreatment regimen or the new treatment regiment. The selected treatmentregimen(s) will be combined if necessary and assigned as a treatmentplan for a specific patient. The plan will be compared with thepatient's known history to determine if there are identifiableincompatibilities. The method includes monitoring the administration ofthe treatment plan and issuing a reminder if a task associated with thetreatment regimen is not completed on time. The method further includesmonitoring the administration of the treatment plan, issuing an alert ifa success indicator associated with the treatment regimen is notachieved and identifying other patients undergoing the same treatmentregimen. The method also can include monitoring the selected performancemeasures associated with the treatment regimens.

The method can include generating visual controls to enable healthcareproviders to anticipate and/or react to problems associated withadministration of the treatment plans. The method also can includeevaluating the treatment regimens and storing in the database only thosetreatment regimens that are effective. The system further can includeusing the data in the database to perform at least one of treatmentplanning, treatment monitoring, hospital monitoring, healthcareinsurance billing, patient billing, research and analysis support,supply chain management and personnel scheduling.

DESCRIPTION OF THE DRAWINGS

The above, as well as other advantages of the present invention, willbecome readily apparent to those skilled in the art from the followingdetailed description of a preferred embodiment when considered in thelight of the accompanying drawings in which:

FIG. 1 is a block diagram of the treatment management system inaccordance with the present invention;

FIG. 2 is flow diagram of the operation of the treatment planning moduleshown in FIG. 1;

FIG. 3 is flow diagram of the operation of the treatment monitoringmodule shown in FIG. 1;

FIG. 4 is flow diagram of the operation of the hospital performancemonitoring module shown in FIG. 1;

FIG. 5 is flow diagram of the operation of the research and analysissupport module shown in FIG. 1; and

FIG. 6 is a block diagram showing the connections between the componentsof the treatment management system in accordance with the presentinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

U.S. provisional patent application Ser. No. 60/692,627 filed Jun. 21,2005 is hereby incorporated herein by reference.

1.0 System Overview

A medical treatment management system (TMS) 10 in accordance with thepresent invention is shown in FIG. 1. A TMS database 11 is at the centerof a plurality of modules that communicate information required by thesystem 10. The overall purpose of the TMS is to improve quality andlower the cost of inpatient hospital care. The TMS is designed to impactpatient care immediately and capture information that can be used toanalyze past events and improve future performance.

The modules that communicate with the TMS database 11 are:

-   Treatment Planning module 12-   Treatment Monitoring module 13-   Hospital Performance Monitoring module 14-   Healthcare Insurance Billing module 15-   Patient Billing module 16-   Research & Analysis Support module 17-   Supply Chain Management module 18-   Personnel Scheduling module 19    2.0 Treatment Planning

2.1 The Treatment Planning module 12 draws on treatment regimens indexedby diagnosis in the TMS database 11. A treatment regimen may include avariety of “treatment events” such as:

-   -   medications delivered in specific doses in specific intervals,    -   physical therapy activities to manipulate a patient manually,    -   surgical procedures,    -   recurring events that capture information such as dietary        requirements,    -   a wide variety of tests and images used to determine the        patient's condition and reaction to treatment.

The treatment regimen is a collection of these events that occur insequence and possibly at specific time intervals. It is intended toinclude everything the hospital must do to treat a patient. Treatmentsequence may be dependent on other treatments. For example, a specifictest may be required at a certain time interval after a specificmedication is administered or a particular surgical procedure isperformed. For treatments other than tests or other activities whosesole function is information gathering, specific success criteria willbe defined as well as known indicators that the treatment is notworking. These criteria could be measurable results or more subjectivein nature (i.e., “the patient should be experiencing less pain withinone hour of taking this medication.”).

When the treatment regimen is to be applied to a specific patient, theregimen will be compared to all information known about the patient(e.g., existing medications, allergies, etc.) to identify any unsuitableaspects of the treatment regimen for this particular patient. Thisincludes functions such as those provided by traditional CPOE systemsthat support prescribing medications. It is also intended to includeissues such as ambulatory limitations, allergies to food or other itemsthat might be encountered in a hospital environment (e.g., latex), etc.

As a physician initially examines a patient, observations and testresults are captured in the patient's history. As shown in FIG. 2, thetreatment planning module 12 begins with a step 20 of retrieving thepatient history from the TMS database 11. In a step 21, new observationsand test results are stored in the patient history in the database. Whenthe physician settles on a diagnosis in a step 22, the system can beused to identify alternative treatment regimens for the given diagnosiswherein all treatment regimens relevant to the diagnosis are retrievedfrom the database in a step 22. The physician can create a new treatmentregimen or customize an existing treatment regiment in a step 24. Thephysician then assigns one or more treatment regimens as the treatmentplan for the patient in a step 25. The system compares the treatmentplan with the information in the patient history in a step 26 to verifythat the plan is compatible with the history. In the simple case ofdiagnosing a single condition, the physician can accept a standardtreatment program, customize an existing treatment regimen or create anentirely new treatment regimen in a step 24. If the physician chooses tocustomize or create a treatment regimen, that regimen can be saved forfuture use by that physician. Hospital administration will have theability to allow access to these new treatment regimens by allphysicians at the hospital. After the plan verification, treatmentmonitoring is activated in a step 27.

2.2 Physician has Ultimate Responsibility and Control

The system will assist in merging treatments for compound diagnoses butTHE DOCTOR ALWAYS HAS ULTIMATE RESPONSIBILITY for ensuring that thetreatment plan will be safe and effective. In the more complex case oftreating one patient with multiple conditions, the physician will selecta treatment regimen for each diagnostic code. The system will thencreate a preliminary treatment regimen for the specific patient bycombining these treatment regimens. To the extent possible, the systemwill check for interactions between the combined treatment events andflag any questionable interactions. It will be the physician'sresponsibility to review the resulting treatment regimen and customizeit as necessary to ensure the proper treatment regimen is ordered forthis patient. Again, the physician will have the ability to save anycustomized treatment regimens so they never have to perform the samecustomization twice.

3.0 Treatment Monitoring

3.1 Monitors the Execution of the Physician-Approved Treatment Plan

The Treatment Monitoring module 13 of the system 10 will monitor thepatient's treatment for events as shown in FIG. 3. Such events includetest results in a step 29, automated treatment delivery services in astep 30, treatment provider observations/alerts in a step 31, automatedpatient monitoring devices in a step 32, and TMS system alerts in a step33. All of the events generated in the steps 29 through 33 are recordedin the database in a step 34. At a decision point 35, each event ischecked as it occurs to determine whether the outcome is according tothe treatment plan. If the outcome is according to plan, the methodbranches at “yes” and returns to the monitoring for the next event tooccur or that has occurred. If the outcome is not according to plan, themethod branches at “no” to a decision point 36. The decision point 36determines whether there is an underlying regiment defect causing theoutcome. If there is a defect, the method branches at “yes” to a step 37wherein a system alert is set for all affected patients and thetreatment regimen is corrected in the database. If there is no defect,the method branches at “no” to a step 38 wherein an alert is issued tothe applicable healthcare providers. Next, the method executes a step 39wherein the patient's treatment plan is adjusted as necessary andreturns to the monitoring for the next event to occur or that hasoccurred.

The steps 36 through 39, for example, may deal with a task required bythe treatment regimen that was not delivered in a timely fashion. Thesystem will remind the healthcare provider responsible for completion ofthe task in the step 38. The system will continue to monitor thedelivery of the treatment regimen and if the task is still notcompleted, an escalation process will begin. In the case of a treatmentthat is inconsistent with the treatment regimen, e.g. an incorrectmedication dosage from an infusion pump, the responsible health careprovider will be immediately notified with an alert. Escalation ofnotices for treatments inconsistent with the treatment regimen will bevery rapid.

Success/failure indicators for specific treatments will have a defaultbehavior as follows. If a specified success indicator does not occur, alow priority alert will be delivered to the attending nurse and will bedelivered to the attending physician during the physician's next reviewof the patient record. The treatment regimen can require a higherpriority alert for specific success/failure indications. For example,the occurrence of the indicator might trigger immediate paging of thephysician and a high priority alert for the attending nurse or otherhospital staff. These alerts can be customized during the creation ofthe treatment regimen database and further customized when the regimenis applied to a specific patient.

3.2 Monitors the Patient for Unexpected Responses to the Treatment

As described above, each treatment regimen will include the definitionof indications that the treatment is working as expected. For example,the patient's temperature may be expected to lower by a certain amountin a certain timeframe. The average clotting time for a patientreceiving a blood thinner might be expected to follow a predictableprogression, etc. The patient's condition might be provided by patientmonitoring equipment, test results or healthcare provider observations.In the event that the patient is not responding to the treatment asexpected, the appropriate health care providers will be notified asspecified in the treatment regimen. Information sources that willprovide success/failure indicators could include staff interviews of thepatient, continuous monitoring equipment linked to the hospital wirelessarea network (see below), lab results entered for the patient, orradiologist interpretation of imaging results.

There will of course be indicators of treatment success, failure orcomplications that are not anticipated in the treatment regimen. Anyperson that is responsible for delivering any portion of the treatmentcan raise an alert based on their judgment and observation of thepatient's condition. The default system action will be to issue a highpriority alert to the attending nurse, nursing supervisor, doctor oncall and the patient's primary physician. However, the priority levelsof the alerts in the default action can be customized by the hospitaladministration. The hospital administration can also add specificadministrators that should be alerted in the event that problems areidentified in a standard treatment regimen. The action taken in aspecific case can also be customized by the person raising the alert.Regardless of any customization, at a minimum an alert will be deliveredto the individuals mentioned above at some level of priority. The intentis not only to provide immediate assistance to the patient question butto quickly identify problems with standard treatment regimens before theproblems can proliferate to additional patients.

When a problem is identified in a standard treatment regimen, theattending physician will have the ability to identify all of his or heradditional patients that are being treated with that treatment regimenor a customized regimen based on the standard treatment regimen in astep 37. Hospital administration will have the same ability across theentire hospital. This will ensure that the standard treatment regimenswill quickly improve and that the improvements will immediately bepropagated to all affected patients. In effect, this will be a keymechanism used to facilitate the hospital's transformation to a learningorganization.

3.3 Inputs from Healthcare Professionals Linked to Wireless AreaNetworks

Doctors, nurses and other health-care providers will access the systemthrough portable devices that allow two-way communication with thesystem. At a minimum, this communication will be through one or morewireless area networks within the hospital. It may also includeappropriately secure access through the Internet. Examples of the typeof devices that might be suitable would include:

-   -   Laptops (possibly using speech recognition)    -   Tablet PC's    -   PDA's (potentially with bar-code readers)    -   Small, portable PC's that project keyboards and monitor displays        onto any flat surface

All portable or shared input devices should have the capability of usingbiometrics to identify the user of the device quickly and easily. Onesuch example might be a fingerprint reader incorporated into the device.Non-portable devices used for input that do not have equivalentfunctionality should be connected to a security system that identifiesthe (one) individual given access to the secure area containing thedevice. The security system must be capable of detecting both the entryand exit of the authorized user and any other potential users. If anypotential unauthorized users have entered the secure area, the deviceconnection will be treated as not secure regardless of the presence ofan authorized user.

3.4 Inputs from Automated Devices

Health care providers will be responsible for creating the link betweenan automated device and the patient. For example, when a nurse connectsthe patient's IV to an infusion pump that is connected to the wirelessarea network, he or she will identify the patient attached to the devicefor the system. This may be done by bar-code scanning of a patientbracelet, reading an RFID tag on the patient or some similar technology.If the device is turned off, the link will be broken. Examples of suchautomated devices might be:

-   -   imaging systems    -   infusion pumps or other treatment delivery systems    -   a wide variety of patient monitoring devices        4.0 Hospital Performance Monitoring

4.1 Performance Measures for Hospital Administration

The Hospital Performance Monitoring module 14 of the system 10 willinclude the ability to analyze the records of patient visits to capturea picture of the hospitals performance that can be used by hospitaladministration to continually improve treatment quality and reducecosts. Performance in this context can be viewed from a number ofperspectives with a number of different measures. Different measuresmight reflect treatment quality, financial performance, legal liabilitycosts or the performance of specific medical teams or staffers. It willbe the hospital administration's responsibility to decide which measureswill be used in for what purposes they will be employed. (See sections“4.2 Performance measures for public consumption” and “4.4 Visualcontrols”.) As shown in FIG. 4, a first step 40 is to retrieve a datasubset selected by the user. A next step 41 is to verify userauthorization. At a decision point 42, a check is made and the methodbranches at “no” is the data is not for internal hospital use. A step 43is performed to ensure that the subset retains patient confidentialityand the method joins a “yes” branch from the decision point 42. At adecision point 44, if a report is not defined, the method branches at“no” and enters a step 45 wherein the data subset is downloaded from thedatabase 11. A defined report causes a branch at “yes” and the methodenters a step 46 wherein a report is prepared or a visual control (SeeSection 4.4) is generated.

4.2 Performance Measures for Public Consumption

The system will capture performance measures similar to existingmeasures reported in public documents such as the Leapfrog Survey. Suchmeasures could be used to provide credible data that can be used in thehospital's marketing efforts. Thus, the collected data is organized in astep 40 and reports of the various measures are generated in a step 46.These measures might be provided in the form of brochures that areupdated quarterly or even in automated displays in public areas thatprovide real-time information wherein information is published. Hospitaladministration should have great flexibility in determining whatmeasures to use and how to use them.

4.3 Example

An enormous amount of information is captured by the system. Hospitaladministration can use this information to provide measures ofperformance from a number of perspectives. The list below provides someexamples but it barely scratches the surface of what is possible.

-   -   mortality rates    -   average cost per patient stay    -   average cost per patient-year for a given population    -   number of patients cared for annually per bed    -   average annual liability costs per bed    -   any of the above broken out by medical specialty, practitioner,        diagnosis, medication, surgical procedure, etc.    -   vacancy rates

4.4 Visual Controls

Many visual controls already exist in a hospital setting. For example,if the ER waiting room is overflowing, is an obvious indicator that thesystem is not handling the load. The information captured by the TMSsystem will give hospital administration the ability to createadditional visual controls in the step 46. These controls will appear inareas easily accessible by the staff and may or may not be visible tothe patients. The intent of these controls is to allow the staff toanticipate problems before they occur. For example, the anticipatedqueue size for medical imaging equipment based on treatment ordersacross the hospital might be displayed for relevant staff members. Forareas where just-in-time inventory control is not appropriate, inventorylevels of critical supplies might be displayed in real-time. Many ofthese controls will have to be based on hospital size, medical specialtyinvolved or other implementation specific details. The system willprovide the flexibility to customize visual controls for specificimplementations.

5.0 Healthcare Insurance Billing/Patient Billing

The treatment management system 10 according to the present inventionwill have the ability to provide automatic, timely and accurate invoicesto responsible parties through the Healthcare Insurance Billing module15 and the Patient Billing module 16. The diagnosis code used to indexthe treatment regimen data either will be identical to or mapped to theDRG codes used for insurance billing. The system will have knowledge ofall supplies, services and facilities used in treating the patient andcan therefore bill accordingly. The system will have the capability tosupport electronic billing or produce printed bills as needed by theresponsible party or parties.

6.0 Research & Analysis Support

6.1 Efficacy of Treatment Regimens

For certain types of doctor and hospital services, the consumption ofthe services is closely correlated to the locally available supply. Theuse of these supply sensitive services accounts for a major portion ofthe variation in per capita healthcare cost between geographic regions.Studies have shown that healthcare costs in more expensive regions canbe three times that of lower-cost regions. The Dartmouth Atlas Projectprovides a wealth of information on variations in treatment regimens andcosts in different regions of the United States. For more informationsee “http://www.dartmouthatlas.org”. There was no statisticallysignificant variation in quality measures such as mortality ratesbetween regions. In other words, the increased expenditures did notresult in any readily apparent improvement in medical quality.

There are also instances where treatment regimens vary because medicalscience has not advanced sufficiently to show that a particulartreatment regimen has a clear advantage. In such cases, doctors must usetheir own opinions. While this will always be the case, this system 10captures both the treatment regimens and the associated outcomes withthe Research & Analysis Support module 17. This will allow medicalresearchers to assess aggregate data and compare different treatmentregimens for similar diagnoses. Combined with the self learning natureof the system, more effective treatment regimens should emerge much morequickly and be stored in the system. Again, both cost and quality wouldbe impacted. Analysis and publication of the data captured by thetreatment monitoring systems should lead to a substantial increase intreatment standardization.

As shown in FIG. 5, the method starts with a step 50 of verifying userauthorization. Next, a data subset selected by the user is retrievedfrom the database 11 in a step 51. A step 52 ensures that the subsetretains patient confidentiality. In a decision point 53, if a report isnot defined, the method branches at “no” to a step 54 wherein the datais downloaded. If a report is defined, the method branches at “yes” to astep 55 to prepare the report.

6.2 Impact on Health Care Cost for Specific Patient Populations

The treatment management system 10 will capture sufficient informationto estimate the impact of the system itself on the quality and cost ofany patient population for which there is a sufficient sample size. Thismight be based on demographics such as identifying the impact ongeriatric patients or children. Health-care insurance providers may wishto compare the cost of healthcare for their customers that use hospitalsthat have implemented the treatment management system versus those thatuse hospitals that have not implemented it. Differences in cost andquality across geographic regions could be analyzed. The potentialcombinations are too numerous to list here.

6.3 Expansion of Hospital Performance Measurement

The cost and quality of health care delivered can be compared acrosshospitals or groups of hospitals within the same hospital system. Agiven hospital system might compare the performance of hospitals indifferent metropolitan areas, geographic regions, etc. If the data weremade publicly available, comparisons across hospital systems would bepossible.

6.4 Analytical Support Related to Liability

Given the litigious nature of our society, hospitals and physicians willbe involved in malpractice litigation no matter how high the quality ofthe care they provide. Malpractice attorneys tell their clients that thebest way to avoid legal difficulties is “document, document, anddocument!” The system provides very detailed documentation of eachpatient's treatment. Reporting facilities will be provided forlitigation support.

The system 10 will also capture liability expenses related to diagnoses.This information can be used by the hospital administration to documentlower liability expenses for their providers of liability insurance.This documentation can be used to justify lower insurance premiums forthe hospital.

6.5 Combinations of the Above

The system 10 will provide a very flexible analysis capability. The keylimitation on this capability will be to ensure that any subset of thedata to be analyzed is of sufficient size to ensure patientconfidentiality. This analysis capability can be used to helpstandardize on the most effective treatment regimens, quickly identifyunexpected side effects of new medications and in general, dramaticallyimproving the quality of health care provided to the public.

7.0 Supply Chain Management

7.1 Implementation of Lean Manufacturing Concepts

By capturing information about the current usage of medications andother supplies through the Supply Chain Management module 18, the system10 will allow much tighter inventory control. The system will useconcepts similar to those in lean manufacturing systems to improvequality and eliminate waste. Consumable supplies will be replenished asthey are used (in much the same way that kanban systems work inautomobile manufacturing). Just-in-time practices will allow hospitalinventories to be minimized such that inventories will not substantiallyexceed levels needed for emergency services.

For this process to work in any facility (manufacturing, medical orotherwise), the facility manager must have the ability to controlproduction to the extent that an even level of output can be produced.For large hospitals most of the activities will approximate this evenlevel of output simply because of the law of large numbers.Unfortunately, for smaller hospitals and for low-volume specialtieswithin larger hospitals, this even level of output would not bedependable. As a result, the system will provide the ability to use amore traditional inventory management approach when JIT methods are notappropriate.

7.2 Inventory-Related Security Issues such as Management of ControlledSubstances

By increasing the number of inventory turns, the time required toidentify a discrepancy in the inventory levels of any controlledsubstances would be greatly reduced. Should anyone attempt to steal anyof these managed supplies, hospital administration would be quicklyalerted to the possibility of theft.

In addition, the use of individual identification at the dose levelwould allow the source of any defective medications to be quicklyidentified. This could be implemented through any appropriate technologysuch as bar-code labels or RFID tags. For example, the system 10 wouldbe able to identify the location of all medications from a defectivelot. Any recalled medications could be quickly located and returned tothe manufacturer. The same capability could be applied to other suppliesof a sensitive nature.

7.3 Improved Support of Purchasing and Accounts Payable Functions

Purchasing at the tactical level will be largely automated. Onceappropriate agreements are in place with the suppliers, the system willplace orders based on the actual consumption of supplies. (As notedabove, more traditional inventory control methods such as calculatedeconomic reorder points can be used where substantial volumefluctuations make JIT inappropriate) Suppliers could be automaticallypaid on receipt of delivery without waiting for an invoice.

8.0 Personnel Scheduling

8.1 Immediate Detection of Personnel Overload/Imbalance

Because each treatment event in a treatment regimen is assigned to aparticular role (e.g., nurse, radiologist, etc.), the system hascomplete knowledge of the short-term requirements for skilled staff.Based on hospital administration supplied parameters, personneloverloads or imbalances in general can be quickly identified using thePersonnel Scheduling module 19. Work cells based on medical specialtycan be identified and allocated based on expected demand. This techniquewill facilitate rapid movement of patients through the hospital whenappropriate and provide an allocation unit that can be used to reactquickly to demand fluctuations.

8.2 Improved Productivity

Using automated medical records and the best available input devices,the time required to complete their responsibilities by hospital staffin general will be reduced. For example, in some hospitals nurses endingtheir shift must have a significant overlap with the incoming nurse tobrief them on the patients that will be under their care. While thefunction will still be required, the system should dramatically reducethe time required for the briefing.

Physicians entering a treatment regimen that they have used before cando it much more efficiently. Physician productivity will continue toimprove as they use the system. The use of work cells based aroundmedical specialties will streamline the treatment of patients aftertheir initial diagnosis. (It may be very appropriate to measure bothtreatment quality and quantity produced by the medical teams functioningwithin work cells.)

9.0 TMS Database

9.1 Stored Data Such As:

The TMS database 11 underneath the system will contain a variety ofstored information. Some of the major categories that will be capturedare as follows:

-   -   treatment regimens by diagnosis    -   treatment plan by patient    -   patient history    -   patient billing information    -   healthcare insurance provider information    -   hospital employee information    -   hospital facility information    -   vendor information

9.2 Event Driven Control Structure

In addition to the more common stored information, the system will alsocapture information about events. This information will be used to drivethe control structure operating the treatment process. In general, twotypes of events will be tracked:

-   -   Planned events such as removing a cast or administering the next        dose of medication    -   Ad hoc events such as an adverse reaction to the treatment plan.

System actions will be triggered by the occurrence of an event. For mostevents, an input from a healthcare provider or an automated device willindicate that an event has occurred. The system action triggered by theevent may be as simple as recording the event in the patient's history.Depending on the nature of the event, the system might react bynotifying a healthcare provider that the patient has had an adversereaction to the treatment regimen. Planned events have a time basedcomponent. When the event is planned, a future time based event isrecorded. If the planned event takes place before the associated timebased event, the time based event will be deleted. If not, the timebased event will serve to notify the system that the planned event didnot occur on schedule and the appropriate action should be taken. Theseplanned events will be stored as part of the treatment management systemdatabase.

10.0 Implementation Issues

10.1 Architecture

As discussed above, the system 10 will be based on an event drivenarchitecture. It must also be kept in mind that the patient will bemobile. Input devices providing information about the patient or thetreatment regimen may be connected to multiple PCs throughout thenetwork. For example, the patient may be taken from their room to usefacilities in another part of the hospital. Such facilities mightinclude everything from showers to medical imaging equipment. Monitoringequipment connected to them may move from being wirelessly connected toa PC in a nursing station to being wirelessly connected to a PC inradiology. A radiologist may use that same PC to transfer images to thepatient's history. Using technologies such as wireless networks andRFID, the capabilities of the system should move with the patientthroughout the hospital. While not required for every implementation,access by remote physicians could be provided via the Internet.

10.2 Security

The system must have very high standards for security andconfidentiality. In particular, it must be compliant with HIPPA. Thisimplies that all wireless area connections must be encrypted. Similarly,VPN technology and other emerging technologies should be used to ensurethat any Internet access is secure. All devices providing access to thesystem must have the ability to identify the user of the devicebiometrically. All inputs to the system must include validation of theuser. This validation must be both quick and accurate. Fingerprintreaders would be an example of a technology that would be suitable forthis purpose. In addition, patient specific information stored in thedatabase must be encrypted.

10.3 Expandability

While initial implementations of the system will be focused on specifichospitals, the architecture and design should facilitate access topatient records across entire hospital systems. This would be expandedto provide access from remote physicians' offices for those physiciansassociated with the hospital system. Access to a particular patient'sinformation across hospital systems anywhere in the world would beprovided in a full implementation.

10.4 Components of the System

FIG. 6 is a block diagram showing the connections between the componentsof the treatment management system 10. A network 60 includes the TMSdatabase 11 connected for data exchange with at least one computer 61.The computer 61 runs software that performs all of the data storage andretrieval associated with the database 11 as described above. Ahealthcare provider terminal 62 represents multiple input/output devicesof various types utilized by doctors, nurses, lab technicians, etc. toexchange data with the computer 61. A monitoring device 63 representsvarious medical devices used in the treatment regimen that exchange datawith the computer 61. An administration terminal 64 represents one ormore input/output devices of various types utilized by hospitaladministrators, managers, etc. to exchange data with the computer 61. Avisual controls block 65 represents the devices described in Section 4.4above that exchange data with the computer 61.

In accordance with the provisions of the patent statutes, the presentinvention has been described in what is considered to represent itspreferred embodiment. However, it should be noted that the invention canbe practiced otherwise than as specifically illustrated and describedwithout departing from its spirit or scope.

1. A patient treatment management system for a hospital comprising: atleast one database for storing data related to a patient includingobservations, test results, diagnosis, at least one treatment regimenand a treatment plan; at least one healthcare provider terminal for useby healthcare providers to exchange said data with said database; atleast one monitoring device for sending medical device operating datarelated to the patient during the administration of the treatment planto said database; and a computer connected to said at least onedatabase, said at least one healthcare provider terminal and said atleast one monitoring device and generating an evaluation of thetreatment regimen based upon said data.
 2. The system according to claim1 including at least one visual control connected to said computer forcommunicating to the healthcare providers information related to apotential problem associated with the treatment regimen.
 3. The systemaccording to claim 1 including at least one administration terminalconnected to said computer for use by administrators to select andmonitor performance measures of the treatment regimen.
 4. The systemaccording to claim 1 including a software program operated by saidcomputer and having at least one of a treatment planning module, atreatment monitoring module, a hospital monitoring module, a healthcareinsurance billing module, a patient billing module, a research andanalysis support module, a supply chain management module and apersonnel scheduling module.
 5. A method for managing patient treatmentcomprising the steps of: a. providing a database; b. storing in thedatabase data related to patients including observations, test results,diagnoses and treatment regimens; c. storing in the database medicaldevice operating data related to the treatment regimens; and d.evaluating effectiveness of the treatment regimens based upon the datastored in the database.
 6. The method according to claim 5 includingdetermining a diagnosis for a patient based upon the stored observationsand test results data, identifying all of the stored treatment regimensassociated with the diagnosis, either customizing one of the identifiedtreatment regimens or creating a new treatment regimen, and storing inthe database the customized treatment regimen or the new treatmentregiment.
 7. The method according to claim 5 including monitoring theadministration of the treatment regimen and issuing a reminder if a taskassociated with the treatment regimen is not completed on time.
 8. Themethod according to claim 5 including monitoring the administration ofthe treatment regimen and issuing an alert if a success indicatorassociated with the treatment regimen is not achieved.
 9. The methodaccording to claim 8 including identifying other patients undergoing thesame treatment regimen.
 10. The method according to claim 5 includingmonitoring the selected performance measures associated with thetreatment regimens.
 11. The method according to claim 10 includinggenerating visual controls to enable healthcare providers to anticipateproblems associated with administration of the treatment regimens. 12.The method according to claim 5 including evaluating the treatmentregimens and storing in the database only those treatment regimens thatare effective.
 13. The system according to claim 5 including using thedata in the database to perform at least one of treatment planning,treatment monitoring, hospital monitoring, healthcare insurance billing,patient billing, research and analysis support, supply chain managementand personnel scheduling.
 14. A method for managing patient treatmentcomprising the steps of: a. providing a database; b. storing in thedatabase a patient history for each patient including data related toobservations, test results, diagnoses and treatment regimens associatedwith the patient; c. administering to each patient at least one of thetreatment regimens based upon the diagnosis; d. storing in the patienthistories in the database medical device operating data related to theadministration of the treatment regimens; e. issuing a reminder if atask associated with one of the treatment regimens is not completed ontime; and f. evaluating effectiveness of the treatment regimens basedupon the data stored in the database.
 15. The method according to claim14 including monitoring the administration of each of the treatmentregimens and issuing an alert if a success indicator associated with anyone of the treatment regimens is not achieved.
 16. The method accordingto claim 15 including identifying other patients undergoing the sametreatment regimen.
 17. The method according to claim 14 including eithercustomizing one of the stored treatment regimens or creating a newtreatment regimen and storing in the database the customized treatmentregimen or the new treatment regiment.
 18. The method according to claim14 including monitoring selected performance measures associated withthe treatment regimens.
 19. The method according to claim 14 includinggenerating visual controls to enable healthcare providers to anticipateproblems associated with administration of the treatment regimens. 20.The system according to claim 14 using the data in the database toperform at least one of treatment planning, treatment monitoring,hospital monitoring, healthcare insurance billing, patient billing,research and analysis support, supply chain management and personnelscheduling.